VIVO 65
Report
- Report Number
- 9617566-2024-00001
- Event Type
- Death
- Date Received
- January 12, 2024
- Date of Event
- December 15, 2023
- Report Date
- August 13, 2025
- Manufacturer
- BREAS MEDICAL AB
- Product Code
- NOU
- UDI-DI
- 0732182224003
- PMA / PMN Number
- K160481
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE EIGHT UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON JUL 12, 2024, WHEN THE REPORTER RESPONDED BY E-MAIL TO BREAS. THE REPORTER WROTE: "NO UPDATES UNFORTUNATELY AND WE DO NOT HAVE THE VENT IN OUR POSSESSION YET." THIS MEANS THAT THE DEVICE REMAINS WITH THE POLICE AND THEIR INVESTIGATION IS ONGOING. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE EIGHT UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON SEP 6, 2024, FOR WHICH THE REPORTER DID NOT PROVIDE ANY UPDATE. THE PREVIOUS RESPONSE WAS: "NO UPDATES UNFORTUNATELY AND WE DO NOT HAVE THE VENT IN OUR POSSESSION YET." BREAS HAS NOT RECEIVED ANY UPDATE SINCE THEN. THIS MEANS THAT THE DEVICE REMAINS WITH THE POLICE AND THEIR INVESTIGATION IS ONGOING. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE SIX UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON MAY 20, 2024, WHEN THE REPORTER RESPONDED BY E-MAIL TO BREAS. THE REPORTER WROTE THAT THE DEVICE REMAINS WITH THE POLICE AND THERE ARE NO UPDATES. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE THREE UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE, MOST RECENTLY ON 12 FEB 2024, AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THEREFORE IT IS AT THIS POINT NOT POSSIBLE TO PROCEED WITH THE INVESTIGATION.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE MANUFACTURER HAS MADE TWO UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE RETURNED. THEREFORE IT IS AT THIS POINT NOT POSSIBLE TO PROCEED WITH THE INVESTIGATION.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE FIVE UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON APRIL 11, 2024, WHEN THE REPORTER RESPONDED BY E-MAIL TO BREAS. THE REPORTER WROTE THAT THE POLICE HAD RECEIVED THE CORONER'S REPORT AND THEIR INVESTIGATION IS STILL ONGOING. THEY WILL NOT BE RELEASING THE VENTILATOR UNTIL THE POLICE INVESTIGATION IS COMPLETE. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE FOUR UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON APRIL 5, 2024, WHEN THE REPORTER RESPONDED BY E-MAIL TO BREAS. THE REPORTER HAD NO NEWS SINCE THE PREVIOUS REQUEST, WHEN SHE SAID THAT THEY STILL HAVE NOT HEARD FROM THE POLICE ON THE STATUS OF THE INVESTIGATION. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE FOUR UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON MARCH 11, 2024, WHEN THE REPORTER RETURNED THE PHONE CALL FROM BREAS. THE REPORTER SAID THAT THEY STILL HAVE NOT HEARD FROM THE POLICE ON THE STATUS OF THE INVESTIGATION. THEIR LEGAL TEAM HAD BEEN CONTACTING THE POLICE EVERY WEEK ASKING ABOUT THE STATUS AND THERE IS STILL NO WORD. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE SEVEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON JUN 12, 2024, WHEN THE REPORTER RESPONDED BY E-MAIL TO BREAS. THE REPORTER WROTE THAT THE DEVICE REMAINS WITH THE POLICE AND THEIR INVESTIGATION IS ONGOING. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE EIGHT UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON JUL 12, 2024, WHEN THE REPORTER RESPONDED BY E-MAIL TO BREAS. THE REPORTER WROTE: "NO UPDATES UNFORTUNATELY AND WE DO NOT HAVE THE VENT IN OUR POSSESSION YET." BREAS HAS NOT RECEIVED ANY UPDATE SINCE THEN. THIS MEANS THAT THE DEVICE REMAINS WITH THE POLICE AND THEIR INVESTIGATION IS ONGOING. THEREFORE, IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON NOVEMBER 14, 2024, WITH A PHONE CALL TO THE INITIAL REPORTER. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON DECEMBER 20, 2024, WITH A PHONE CALL TO THE INITIAL REPORTER. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. BREAS IS STILL ATTEMPTING TO GAIN MORE INFORMATION FROM ARRIS HEALTHCARE, MOST RECENTLY ATTEMPTING TO CONTACT THEIR ATTORNEY FOR MORE INFORMATION. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. THE MOST RECENT REQUEST WAS MADE ON SEPTEMBER 24, 2024, WITH A PHONE CALL TO THE INITIAL REPORTER. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. BREAS IS STILL ATTEMPTING TO GAIN MORE INFORMATION FROM ARRIS HEALTHCARE, MOST RECENTLY ATTEMPTING TO CONTACT THEIR ATTORNEY FOR MORE INFORMATION. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. BREAS IS STILL ATTEMPTING TO GAIN MORE INFORMATION FROM ARRIS HEALTHCARE, MOST RECENTLY ATTEMPTING TO CONTACT THEIR ATTORNEY FOR MORE INFORMATION. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. BREAS IS STILL ATTEMPTING TO GAIN MORE INFORMATION FROM ARRIS HEALTHCARE, MOST RECENTLY ATTEMPTING TO CONTACT THEIR ATTORNEY FOR MORE INFORMATION. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. BREAS IS STILL ATTEMPTING TO GAIN MORE INFORMATION FROM ARRIS HEALTHCARE, MOST RECENTLY ATTEMPTING TO CONTACT THEIR ATTORNEY FOR MORE INFORMATION. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. BREAS IS STILL ATTEMPTING TO GAIN MORE INFORMATION FROM ARRIS HEALTHCARE, MOST RECENTLY ATTEMPTING TO CONTACT THEIR ATTORNEY FOR MORE INFORMATION. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION. THE US AGENT HAS MADE OVER TEN UNSUCCESSFUL REQUESTS FOR MORE INFORMATION WITHOUT A RESPONSE. THIS MDR WILL BE CLOSED AT THIS TIME.
THE DEVICE WAS TAKEN BY POLICE UNDER SUBPOENA. LOG FILES WERE NOT RETRIEVED PRIOR TO THIS, AND HAVE NOT BEEN MADE AVAILABLE TO THE MANUFACTURER. THE US AGENT HAS MADE TEN UNSUCCESSFUL REQUESTS TO HAVE THE DEVICE AND WILL CONTINUE TO REACH OUT TO THE REPORTED TO OBTAIN THE DEVICE. BREAS IS STILL ATTEMPTING TO GAIN MORE INFORMATION FROM ARRIS HEALTHCARE, MOST RECENTLY ATTEMPTING TO CONTACT THEIR ATTORNEY FOR MORE INFORMATION. THIS MEANS THAT THE LATEST INFORMATION WE HAVE IS THAT DEVICE IS WITH THE POLICE AND WE HAVE NO INFORMATION THAT THE DEVICE COULD BE RELEASED. THEREFORE IT IS NOT POSSIBLE TO PROCEED WITH THE MANUFACTURER'S INVESTIGATION AT THIS TIME.
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER K450103. AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER K450103. AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER K450103. AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER K450103. AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER (B)(6). AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT (B)(6). THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
ON 17 DECEMBER 2023 BREAS MEDICAL WAS INFORMED ABOUT THE FOLLOWING: "ON (B)(6) 2023 PATIENT WAS PLACED ON THE VENTILATOR AROUND 4:30PM PER REPORTS AND STATEMENTS FROM STAFF. THE VENTILATOR WAS A VIVO 65 SERIAL NUMBER K450103. AROUND 6PM THE PATIENT WAS FOUND DECEASED AND THE VENTILATOR WAS NOT WORKING AND HAD GONE INTO STANDBY MODE. THIS EVENT OCCURRED AT CASCADIA OF COEUR D'ALENE. THE VENTILATOR WAS CONNECTED TO AN SAI ALARM SYSTEM WHICH SHOWS NO ALARMS OCCURRED DURING THIS TIME FRAME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1707016 | VIVO 65 | VENTILATOR | NOU | BREAS MEDICAL AB | 224000 | 0732182224003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |